Trajenta Duo

Per 2.5 mg/500 mg FC tab Linagliptin 2.5 mg, metformin 500 mg. Per 2.5 mg/1,000 mg FC tab Linagliptin 2.5 mg, metformin 1,000 mg

Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM when treatment w/ both linagliptin & metformin is appropriate, in patients inadequately controlled on metformin alone or those already being treated & well-controlled w/ free combination of linagliptin & metformin. In combination w/ sulphonylurea (ie, triple combination therapy) as adjunct to diet & exercise in patients inadequately controlled on their max tolerated dose of metformin & sulphonylurea. In combination w/ empagliflozin (ie, triple combination therapy) as adjunct to diet & exercise in patients inadequately controlled on their max tolerated dose of metformin & SGLT2 inhibitor. Add-on to insulin (ie, triple combination therapy) as adjunct to diet & exercise to improve glycaemic control in patients when insulin & metformin alone do not provide adequate glycaemic control.

Adult w/ normal renal function (GFR ≥90 mL/min): Patient never treated w/ metformin Individualized dosage. Recommended dose: Linagliptin 2.5 mg + metformin 500 mg bid. Max: Linagliptin 2.5 mg + metformin 1,000 mg bid. Patient inadequately controlled on max tolerated dose of metformin monotherapy Initially linagliptin 2.5 mg bid + metformin dose already being taken. Patient switching from co-administration of linagliptin + metformin Initially at the dose of linagliptin & metformin already being taken. Patient inadequately controlled on dual combination therapy w/ the max tolerated dose of metformin & a sulphonylurea Linagliptin 2.5 mg bid (5 mg total daily dose) & similar dose of metformin already being taken. Lower dose of sulphonylurea is required when used in combination therapy. Patient inadequately controlled on dual combination therapy w/ insulin & max tolerated metformin dose Linagliptin 2.5 mg bid (5 mg total daily dose) & similar dose of metformin already being taken. When used in combination w/ insulin, lower dose of insulin may be required. Renally impaired patient w/ eGFR 60-89 mL/min Max daily dose: Metformin 3,000 mg, 45-59 mL/min Max daily dose: Metformin 2,000 mg. Starting dose is at most half of max dose, 30-44 mL/min Max daily dose: Metformin 1,000 mg. Starting dose is at most half of max dose, <30 mL/min Metformin is contraindicated.

Should be taken with food: Take w/ meals to minimise GI effects.

Hypersensitivity. Acute metabolic acidosis eg, lactic acidosis, diabetic ketoacidosis; diabetic precoma. Acute conditions w/ potential to alter renal function eg, dehydration, severe infection & shock. Disease causing tissue hypoxia (especially acute, or chronic disease worsening) eg, decompensated heart failure, resp failure, recent MI, shock. Acute alcohol intoxication, alcoholism. Hepatic impairment. Severe renal failure (CrCl <30 mL/min or estimated GFR <30 mL/min/1.73 m²).

Discontinue use if acute pancreatitis occurs or is suspected; in case of suspected symptoms of lactic acidosis; prior to or at the time of imaging procedure w/ iodinated contrast agents & do not restart until at least 48 hr after, provided that renal function has been re-evaluated & found to be stable; at the time of surgery under general, spinal or eperidural anaesth & restart no earlier than 48 hr following surgery or resumption of oral nutrition provided that renal function has been re-evaluated & found to be stable; if bullous pemphigoid is suspected. Discontinue temporarily if patients undergo intravascular administration of iodinated contrast media or operation requiring diet of food & fluid/drinking water; in case of dehydration; in the presence of conditions that alter renal function. Not for patients w/ type 1 diabetes or ketoacidosis; severe infection & accident. Hypoglycaemia; lactic acidosis; bullous pemphigoid. Decreased blood pH (<7.35), increased plasma lactate levels (>5 mmol/L), & increased anion gap & lactate/pyruvate ratio. Dizziness or fainting. Increased risk of severe joint pain; low vit B₁₂ levels w/ increasing metformin dose, treatment duration &/or risk factors causing vit B₁₂ deficiency. Patients w/ heart failure. Deficient caloric intake; strenuous exercise not compensated by caloric supplementation. Assess GFR before treatment initiation & regularly thereafter; renal function in patients at increased risk of further renal impairment progression & in elderly more frequently eg, every 3-6 mth. Regularly monitor cardiac & renal function in patients w/ stable chronic heart failure. Monitor vit B₁₂ serum levels in case of suspicion of vit B₁₂ deficiency (eg, anaemia or neuropathy). Concomitant use w/ sulphonylureas, insulin; medicinal products that acutely impair renal function eg, antihypertensives, diuretics & NSAIDs; alcoholic beverage. Not to be used during pregnancy & lactation. Not recommended in childn <18 yr. Elderly.

Nasopharyngitis; hypersensitivity, angioedema, urticaria; lactic acidosis, vit B₁₂ decrease/deficiency, hypoglycaemia (when combined w/ sulphonylurea); taste disturbance; cough; decreased appetite, diarrhoea, constipation (when combined w/ insulin), nausea, pancreatitis, vomiting, abdominal pain, mouth ulceration; abnormal LFT, hepatitis; pruritus, erythema, rash, bullous pemphigoid; increased lipase & amylase.

Linagliptin: Decreased steady-state AUC, C_max & dipeptidyl peptidase 4 inhibition w/ rifampicin. Increased plasma AUC & C_max of simvastatin. Metformin: Increased risk of lactic acidosis w/ alcohol & other medicinal products adversely affecting renal function eg, NSAIDs including selective COX-2 inhibitors, ACE inhibitors, angiotensin II receptor antagonists & diuretics, especially loop diuretics. Concomitant use w/ iodinated contrast agents. Reduced efficacy w/ OCT1 inhibitors eg, verapamil. Increased GI absorption & efficacy w/ OCT1 inducers eg, rifampicin. Decreased renal elimination & increased plasma conc w/ OCT2 inhibitors eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole. Altered efficacy & renal elimination w/ OCT1 & OCT2 inhibitors eg, crizotinib, olaparib.

Antidiabetic Agents

A10BD11 - metformin and linagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

NDD